# K051714: Total Bile Acids Assay, Model DZ042A

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Dec 7, 2005 after 163 days
- Product code: KWW (Radioimmunoassay, Cholyglycine, Bile Acids)
- Device class: 2
- Regulation: 21 CFR 862.1177
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K872296 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872296: Bile Acids Reagent, Sigma Diagnostics, Inc. (1987) Summary page 1.

## Indications for use
Total Bile Acids Assay is intended for the in vitro quantitative determination of total bile acids (TBA) in human serum samples. Total bile acids are metabolized in the liver and serve as a marker for normal and abnormal liver function. Serum total bile acids are increased in patients with liver disease. Total Bile Acids Assay contains a bile acid calibrator. The calibrator is design to be used with the assay for the quantitative determination of TBA in serum. Total Bile Acids Assay has control design to be used with the assay for the quantitative determination of TBA in serum.

Source page: https://510kreport.com/device/K051714
Methodology: https://510kreport.com/methodology